New study results on Dulcolax® confirm efficacy and safety

Boehringer IngelheimIn a clinical study Boehringer Ingelheim recently conducted, Dulcolax® tablets with the active ingredient bisacodyl clearly demonstrated efficacy by increasing the frequency and regularity of bowel movements. The Dulcolax® (bisacodyl) treatment significantly improved all measured symptoms of constipation at nearly every time point assessed, also improving the patients' quality of life. In addition, the study also confirmed the well-known safety profile of bisacodyl. The results of the study were presented for the first time at Digestive Disease Week 2010 in New Orleans/USA from 1st to 5th of May.(1)

The new study (randomized, double-blind, multi-center, placebo-controlled, parallel groups) aimed to determine the efficacy and safety of four weeks of treatment with oral bisacodyl tablets 10 mg, taken once daily, in patients with chronic constipation (defined by ROME III criteria). 368 patients were randomized 2:1 to bisacodyl or placebo following a two week baseline period without study medication. Efficacy data were recorded daily in an electronic diary by patients.

One of the worlds leading experts in gastroenterology, Professor Stefan Müller-Lissner, Park-Klinik Weissensee in Berlin/Germany, described the results: "During the four weeks of treatment, the mean number of Complete Spontaneous Bowel Movements per week (primary efficacy variable) was statistically significantly higher in the bisacodyl than in the placebo group (p<0.0001). Oral bisacodyl proved to be an effective, well-tolerated treatment for patients with constipation. It increased bowel frequency and improved the associated symptoms of constipation such as bloating and abdominal discomfort. Moreover, treatment with bisacodyl had a sustained impact: The benefit was maintained over the four week study period."

Also, for the first time, it was shown that treatment with Dulcolax® (bisacodyl) in patients suffering from constipation results in an increase in the quality of life as well as an improvement in the sufferers' everyday functioning and well-being. On top of this, the time to onset of action was confirmed to be from six to twelve hours, dispelling the misconception that laxatives work too quickly.

Under real-life conditions the constipated patient is faced with the essential question in self-medication: How good is the efficacy? The answer to this question decides whether a particular drug will be used again or not. In this trial, the final global efficacy was assessed by the patient after the four weeks treatment period. "80 percent of the patients taking bisacodyl rate the efficacy of the drug as 'good' or 'satisfactory'. The comparisons between treatment groups resulted in highly statistically significant differences in favour of Dulcolax®," Professor Müller-Lissner summarized the results of the assessment.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 15 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.

1. MA Kamm, SA Mueller-Lissner, A Wald, U Hinkel, E Richter, R Swallow, J Bubeck. Stimulant Laxatives are Effective in Chronic Constipation: Multi-Center, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trial of Bisacodyl. Gastroenterology 2010, 138 (5): 228.

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